The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis

NCT04530669 | Completed

• 1 other identifier: P.T. REC/012/002866
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of "High Tone Power Therapy" (HTPT) on fatigue and functional outcomes in multiple sclerosis (MS). BACKGROUND: Fatigue and functional limitations considered serious disorders in patients with multiple sclerosis that lead to impairment of the physical activities and disruption of the quality of life (QOL). HYPOTHESES: This study hypothesized that: High Tone Power Therapy will have a significant beneficial effect on fatigue and functional outcomes in in multiple sclerosis RESEARCH QUESTION: Is there a beneficial effect of High Tone Power Therapy on fatigue and functional outcomes in multiple sclerosis?

Conditions

Multiple Sclerosis

Keywords

High Tone Power Therapy; fatigue; functional outcomes

Outcome Measures

Primary Outcomes (2)

• Expanded Disability Status Scale (EDSS)

  The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. The scale was developed by a neurologist called John Kurtzke in 1983 as an advance from his previous 10 step Disability Status Scale (DSS). The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems

  4 weeks

• Functional Systems Score (FSS),

  On a scale of 0 to 6, the functional system score (FSS) measures how well the major central nervous systems are working and assigns a score to the patient disability. This score uses also information about the gait and use of assistive devices.

  4 weeks

Study Arms (2)

study group

EXPERIMENTAL

in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program

Device: High Tone Power Therapy; Other: exercise program

control group

SHAM COMPARATOR

the sham arm will receive the same physical exercise program with sham "high tone power therapy".

Other: exercise program

Interventions

High Tone Power Therapy DEVICE

High Tone Power Therapy (HiTop 191): (For group I). The high tone power therapy through using a device (HiTop 191; gbo Medizintechnik, Rimbach, Germany). The intensity of the electrical stimulation will be adjusted to a pleasant level that did not produce any pain or discomfort.

study group

exercise program OTHER

physical therapy conventional selected exercise program inform of functional activities of daily living

control group; study group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Both genders
• Age from 18-50 years
• All MS types will be included (relapsing remitting "RR", secondary progressive "SP, and primary progressive "PP")
• Patients with residual motor / cerebellar / sphincteric impairment that are not responding to conventional pharmacological treatments.
• At least 6 months after the last relapse.
• EDSS from 2-6.5.
• All patients should be receiving a disease modifying therapy with stabilization of the disease course for 1 year in case of SPMS and PPMS.
• Patients that can pay regular visits to the physical center without potential interruption.
• Patients who agree to participate and sign the informed consent. - body mass index (20:29) kg/m2

You may not qualify if:

• cognitive impairment that can hinder the ability to communicate or to understand program instructions.
• neurological deficits due to any disease other than MS
• orthopedic abnormalities,
• secondary musculoskeletal complication.
• Patients who refuse participation or signing the informed consent.

Sponsors & Collaborators

• Lama Saad El-Din Mahmoud: lead

Study Sites (1)

Kasr Al-Ainy MS clinic, Neurology department, Cairo University hospitals.

Al Jīzah, Select State, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lama S Mahmoud

  Cairo University

  STUDY DIRECTOR

• Khalid T Turky, PHD

  Ph.D., Assist. prof : Physical Therapy

  STUDY CHAIR

• Nevin M Shalaby, PHD

  Professor of neurology Department of Neurology , Faculty of Medicine, Cairo University.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery

Model Details: active arm and placebo arm; in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program, and the placebo arm will receive the same physical exercise program with sham "high tone power therapy".

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: September 1, 2020
• Primary Completion: October 15, 2020
• Study Completion: December 30, 2020
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)